TPU for Medical Device Solutions
Sixteen grades spanning 75 Shore A to 85 Shore D across six chemistry types — aromatic and aliphatic polyether, polyester, polycarbonate, and rigid TPU. Tubing, balloon and wound-care applications are supplied in natural colour, with radiopaque and custom colour options.
Physical properties
| Grade | Hardness | Density | Tensile | Elongation | Tear | Flame |
|---|---|---|---|---|---|---|
| NLMD8275A | 75A | 1.07 | 25 | 750 | 55 | — |
| NLMD6575A | 75A | 1.14 | 30 | 510 | — | — |
| NLMD8280A | 80A | 1.11 | 32 | 680 | 90 | — |
| NLMD8585A | 82A | 1.2 | 34 | 470 | 72 | — |
| NLMD8285A | 85A | 1.14 | 35 | 650 | 83 | — |
| NLMD6585A | 85A | 1.14 | 34 | 450 | — | — |
| NLMD8185A | 85A | 1.21 | 33 | 600 | 75 | — |
| NLMD8290A | 90A | 1.14 | 43 | 550 | 110 | — |
| NLMD6595A | 92A | 1.14 | 53 | 390 | — | — |
| NLMD8190A | 92A | 1.22 | 47 | 530 | 113 | — |
| NLMD6295A | 93A | 1.1 | 28 | 490 | — | — |
| NLMD8255D | 55D | 1.16 | 49 | 450 | 140 | — |
| NLMD8555D | 55D | 1.2 | 39 | 300 | 140 | — |
| NLMD8265D | 65D | 1.16 | 49 | 440 | 155 | — |
| NLMD8275D | 75D | 1.19 | 62 | 330 | 230 | — |
| NLMD8285D | 85D | 1.2 | 70 | 160 | — | — |
Complete specifications are per the official TDS — request the current technical data sheet.
What sets it apart
Aliphatic polycarbonate backbone: transparent, and far more resistant to hydrolysis and UV yellowing than aromatic grades. The choice for optically clear devices.
The workhorse of the range: 85 Shore A, 35 MPa tensile and 650% elongation give a balance of stiffness and flexibility that suits most catheter shafts.
Aromatic polyester backbone: higher density (1.21) and better oil and abrasion resistance than polyether, at the cost of hydrolysis resistance. Not for steam-sterilised or long-wet-use devices.
The rigid end of the range at 85 Shore D: 70 MPa tensile with only 160% elongation. Used for device housings and stiff connectors, not for flexible shafts.
Questions this line raises
Three answers that come up before a grade is chosen — deliberately short. The technical articles go deeper wherever the answer has a mechanism behind it.
What is a China master file, and does it approve my device?
A master file (MAF) is a reference dossier filed with NMPA holding material-level data — composition, manufacturing, characterisation, biocompatibility — for a material used in a device. It lets a device maker cite our file instead of rebuilding the material chapter of their own submission. It does not approve any device, it does not transfer to you, and it does not replace the device-level ISO 10993 work your product still needs. It shortens the material section of a registration, and that is all it does.
Do you have long-term implant data?
We publish a 52-week intramuscular implantation study on the 95A implant grade: irritation index 0.0 at 52 weeks, no different from the negative control, run at a CNAS-accredited laboratory (report WT252114-1), with subchronic systemic toxicity alongside it. That is material-level evidence for a long-contact application. It is not a device approval, and it does not cover your geometry, your sterilisation or your manufacturing process — those still need their own assessment.
Can I use an industrial grade in a medical device?
Chemically, sometimes the polymer is close; in a submission, the answer is normally no. What separates a medical grade is not only the polymer but change control, lot traceability, documented extractables and a supply agreement that keeps the formulation fixed. An industrial grade can change an additive package without notice, which silently invalidates the biocompatibility data a registration rests on. If a device is the destination, start from the medical range and accept the narrower choice.